There are more than 400,000 people with hemophilia in the world, Chinese surpassing 100,000. The registered hemophilia patients in China are less than 20,000, because most patients give up treatment due to the expensive medical expenses. Those who lack coagulation factor VIII account for 80% to 85% of the hemophilia A patients. Currently, there is no cure for hemophilia, treatment for which on the market are all alternatives. Coagulation factors are the main drugs.
Full report: Investigation Report on Recombinant Human Coagulation Factor VIII in China, 2018-2022
In 1992, Baxter (Baxalta) publicized the first recombinant coagulation factor VIII. Because it has the same effects as natural coagulation factors without risks of blood-borne virus contamination, it is very popular in the market. The developed countries master mature technologies of recombinant coagulation factors. For example, recombinant coagulation factor VIII now has experienced four rounds of upgradation. The main manufacturers are Bayer, Baxalta, Wyeth, etc. By Jun. 2018, no domestic recombinant coagulation factor VIII has been launched. In May 2018, China’s local biopharmaceutical company Beijing Tiantan Biological Products Co., Ltd. announced that its subsidiary Chengdu Rongsheng Pharmaceutical Co., Ltd. had received Approval Document for Clinical Trials of recombinant human coagulation factor VIII for injection issued by the CFDA.
Recombinant human coagulation factor VIII developed rapidly after entering China. Its annual sales increased from less than CNY 6 million in 2009 to CNY 300 million in 2017, and the CAGR reached 65.2% from 2009 to 2017. Currently, recombinant human coagulation factor VIII sold on the Chinese market is all imported from Bayer, Baxalta and Wyeth. Bayer secures the highest market share, which was close to 68% in 2017.
CRI forecasts that with the development of China’s economy, patients with hemophilia are more able to pay medical expenses. It is expected that the market scale of recombinant human coagulation factor VIII in China will continue to increase from 2018 to 2022. After 2022, there is possibility that Chinese companies may launch recombinant human coagulation factor VIII.